Berlin Heart GmbH
DE-MF-000006521 · Germany · Berlin
Berlin Heart GmbH is registered in the European database on medical devices as a manufacturer, with 92 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 70 |
|---|---|
| Class IIa | 13 |
| Class IIb | 9 |
Among these devices, 90 are declared sterile, 66 implantable, 2 active, 1 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BERLIN HEART GMBH (DE) · FDA 3004582654 |
| Devices in EUDAMED | 92 |
| Country of registration | Germany |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 046068 0051 | issued | 2031-06-23 |
G70 046068 0048 | issued | 2029-01-09 |
G15 046068 0067 | issued | 2029-02-06 |